An observational study in Opioid Use Disorder, Substance-Related Disorders and Pregnancy Related, sponsored by Senthil Sadhasivam. Enrolling by invitation at 2 sites in United States. Open to female participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Senthil Sadhasivam · Observational
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Among 1,222 studies in Opioid-Related Disorders with a site in United States — 245 open to participants now, 315 under way, 18 of them phase 3. Opioid-Related Disorders · United States.
Among the 1,222 studies in Opioid-Related Disorders with a site in United States, this one is the 32nd largest by planned enrollment of the 122 observational ones that give a count, is one of 87 that started in 2024, is one of 122 observational ones, reaches primary completion later than 254 of the 314 other live ones, and was the 988th registered.
1,473 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
Browse Opioid-Related Disorders studies →245 of the 1,222 studies in Opioid-Related Disorders with a site in United States are open now. Recruiting first, the newest first:
Washington State University · Sites in United States
Ages 18+
University of Massachusetts, Worcester · Sites in United States
Ages 18+ · Healthy volunteers
Baylor College of Medicine · Sites in United States
Ages 18–64
Yale University · Sites in United States
Ages 25–65 · Healthy volunteers
Adneuris Therapeutics, Inc. · Sites in United States
Ages 18–65
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 210 Opioid-Related Disorders studies recruiting now, 122 (58%) set no upper age limit and 74 (35%) stop at 75 or younger; 14 take children under 18; 53 take healthy volunteers.
This study: 18 Years to 100 Years · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,222 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 162 · Phase 2 245 · Phase 3 99 · Phase 4 79
First in 1988; this study’s year is marked. 87 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 250 is above the median of 129 across 184 observational studies indexed under Opioid-Related Disorders.
Median enrollment 56 across the 1,097 interventional studies, 85 across the 122 observational. Of the 834 that completed or were terminated, 331 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
132 of 1,222 have an industry lead sponsor. The 10 most frequent:
Senthil Sadhasivam is the lead sponsor of 8 studies on the registry; 6 are open to participants now.
Senthil Sadhasivam has 3 studies filed under Opioid-Related Disorders — fewer than ten, so there is no comparison to draw.
129 of the studies in Opioid-Related Disorders with a site in United States that are under way reach primary completion within a year, 9 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05011266Phase 3New York State Psychiatric InstituteEfficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder | 2027-01-01 |
| NCT05834478Phase 3Emory UniversityNon-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3 | 2027-02 |
| NCT05033028Phase 3NYU Langone HealthSmartphones for Opiate Addiction Recovery | 2027-06-01 |
| NCT05459402Phase 3University of Maryland, BaltimoreDivided or Single Exposure (DOSE) Study | 2027-06-01 |
| NCT05766631Phase 3Friends Research Institute, Inc.Treating Polysubstance Use Using a Novel Digital Technology | 2027-06-30 |
Add all 129 to your calendar (.ics) → With an account.
Among the 1,222 studies in Opioid-Related Disorders with a site in United States, from their registry updates:
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The goal of this observational study is to learn about the long term effects of prenatal opioid exposure. The main objectives are:
In this study participants will:
Any woman of the age of 18 or older that is having a single pregnancy, and currently taking buprenorphine or methadone for opioid use disorder.
Pregnant women with opioid use disorder
Inclusion Criteria:
Exclusion Criteria:
Infants with prenatal opioid exposure:
Inclusion:
Exclusion:
Major congenital anomalies or genetic syndromes affecting neurodevelopment
Control Pregnant Women:
Inclusion:
Exclusion:
Control infants:
Inclusion:
Born to control pregnant mother enrolled in study
Exclusion:
Any major congenital anomalies, genetic abnormalities, neurologic abnormalities, syndromes, or chronic medical conditions affecting neurodevelopment.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
150 pregnant mothers with opioid use disorder who are on buprenorphine or methadone treatment
Drug: Buprenorphine or Methadone Treatment · Diagnostic Test: Fetal and Placental MRI · Behavioral: Child Developmental Assessment · Behavioral: Questionnaires · Other: Blood and Placental Samples
100 pregnant mother who to not have a history of opioid use disorder
Diagnostic Test: Fetal and Placental MRI · Behavioral: Child Developmental Assessment · Behavioral: Questionnaires · Other: Blood and Placental Samples
Pregnant mothers must be taking Buprenorphine or Methadone
Two MRIs : * Second Trimester * Third Trimester
At 1 year of life child will receive a developmental assessment
Participants will answer questionnaires on their medical history, pregnancy, substance use, and after birth: their child's development
At each MRI visit a blood sample will be collected for substances, DNA, RNA, epigenetics, and placental biomarkers. At delivery: A sample of placenta will be collected for RNA, DNA, and epigenetic analysis.
Alterations in fetal brain volume
Comparing changes in fetal brain volume using MRI between babies who have had prenatal opioid exposure (POE) and controls
Time frame: Between 20 weeks gestation and delivery
Differences in placenta signal
Comparing differences in placenta signal using MRI between the POE group and controls
Time frame: Between 20 weeks gestation and delivery
Placental epigenetic changes related to POE
Compare placental DNA methylation in POE group and control group
Time frame: Between 20 weeks gestation and delivery
Placental dysfunction biomarkers related to POE
Compare concentrations of blood proteins in POE group vs controls
Time frame: Between 20 weeks gestation and delivery
Neonatal Opioid Withdrawal Syndrome (NOWS) severity
Measuring NOWs severity in the POE group using eat sleep console scores
Time frame: After birth through one year of life
Length of Hospital Stay
Measuring NOWs severity in the POE group using length of hospital stay
Time frame: After birth through one year of life
Ages and Stages Questionnaire Scores during infancy
Comparing neurodevelopment of POE group and controls using the ages and stages questionnaire at multiple time points in baby's first year of life. This questionnaire assesses infants developmental level. Scores can identify whether child is below cutoff and needs professional intervention, close to cutoff and requires more developmental support and learning, or above cutoff and on track.
Time frame: After birth through one year of life
Neurocognitive and behavioral development assessment (Bayley-4) at one year of age
Comparing neurodevelopment of POE group and controls using the Bayley's 4 assessment at one year of age. This assessment is administered by professionals to identify development delays in children.
Time frame: After birth through one year of life
Plan to share: Undecided
No publications or documents are linked to this record.
Started Feb 2024 (actual). Primary completion is estimated for Dec 2028, 57 months after the start.
Of 74 non-industry observational studies under Opioid-Related Disorders, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's planned 57 months is above that.
Counting every sponsor, half of 88 studies reached it within 27 months; a quarter within 13 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Senthil Sadhasivam